Tuesday, February 24, 2009

Classification of FDA inspection

NAI - No Action Indicated
Site is in compliance. No actions or response from site necessary
VAI - Voluntary Action Indicated
Violative practices noted that do not immediately jeopardize subject safety, but require correction action. Response necessary; follow-up inspection possible
OAI - Official Action Indicated
Violations severe enough to warrant immediate administrative actions. Reinspection likely

Other Inspections
Routine GMP audits
Directed audit for a specific reason
Reinspection after a Warning Letter
Recall effectiveness check
Preapproval inspection
Special Enforcement Initiative

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